Biosample aspirator

ABSTRACT

A fine-needle aspirator for collecting a biosample from a subject into a closed sterile system. The aspirator is adapted for use with a variety of needles and comprises a motor driven pump capable of continuous suction in a biosample collection system. The biosample collection system may comprise a biosample connector such as elastomeric tubing in communication with the needle and a collection space in a biosample container whereby a biosample collected by the needle may be transferred to the collection space. A flushing substance flushes the biosample through the biosample collection system. Additives may be added to the biosample after collection in order to treat, preserve or analyze the biosample.

This application is a continuation Ser. No. 07/307,403, filed: Feb. 6,1989, entitled BIOSAMPLE ASPIRATOR, now U.S. Pat. No. 4,982,739.

The present invention relates generally, but not by way of limitation,to methods and devices for obtaining biological samples from a subject.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view in cross section of the biopsy gun constructedaccording to the present invention.

FIGS. 2-5 are horizontal cross sections of the pump housing of thepresent invention. FIG. 5 is the lowest section upon which respectivelysections in FIGS. 4, 3 and 2 are mounted.

FIG. 2 is a top plan view of a cross section of the pump housing of thepresent invention.

FIG. 3 is a top plan view of a cross section of the pump housing of thepresent invention showing a portion of the pump housing component space.

FIG. 4 is a top plan view of a cross section of the pump housing of thepresent invention showing a portion of the pump housing component spaceincluding a portion of the trigger aperture which contains a slidespring attached to the trigger slide shown in a horizontal cross sectionand the rod support member space.

FIG. 5 is a top plan view of the lowest cross section of the pumphousing of the present invention showing a portion of the triggeraperture and the pump housing shaft aperture.

FIG. 6 is a vertical cross sectional view of a portion of the pumphousing of the present without the connectors and the slide spring.

FIG. 7 is a horizontal cross sectional top plan view of a portion of thepump housing of the present invention without the slide spring.

FIG. 8 is an elevational view of the second end of the pump housing ofthe present invention showing the clear plastic container compartmentwith connectors attached to the containers.

FIG. 9 is a schematic drawing of the switch of the present invention inthe open position.

FIG. 10 is a bottom plan view of the rod support member.

FIG. 11 is an elevational side view of the rod support member.

FIG. 12 is an elevational side view of a rod.

FIG. 13 is a top plan view of the control member guide.

FIG. 14 is a side elevational view of the control member guide.

FIG. 15 is a side elevational view of the control member.

FIG. 16 is a side elevational view of the flushing needle.

FIG. 17 is a side elevational view of the obturator needle.

FIG. 18 is a side elevational view of the flanged needle.

FIG. 19 is a schematic drawing of the aspirator in accordance with thepresent invention using a piston pump.

FIG. 20 is a top plan view of a horizontal cross section of theperistaltic pump with the additive connector and the additive regulator.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention comprises a fine-needle aspirator adapted for usein collecting a biosample such as fluid or tissue from a subject such asa human into a closed sterile system. The aspirator is adapted to beused with a needle having a first end and a second end with an openingtherethrough and comprises a biosample collection system and a suctionmeans.

The suction means generates and establishes a vacuum capable ofcontinuous suction in the biosample collection system whereby abiosample received via the first end of the needle is movablytransferred through the needle opening into the biosample collectionsystem. The biosample collection system comprises a biosample collectionarea and a communicating means for establishing fluidic communicationbetween the needle opening and the biosample collection area. Thebiosample collection area may be part of the communication means or maycomprise a biosample container connected to the communication meanshaving a collection space sized to receive at least one biosample.

Referring to the drawings in detail, and particularly FIG. 1, referencecharacter 10 generally designates a biosample aspirator in accordancewith the present invention. The aspirator 10 comprises a handle housinggenerally designated by reference character 12 and a pump housinggenerally designated by reference character 14. A needle 16 having afirst end 18 and a second end (not shown) with an opening (not shown)therethrough is secured to the pump housing 14 as described hereafter.

The handle housing 12 comprises a lower end 24 and an upper end 26 witha front surface 28 and back surface 30. The handle housing 12 is sizedto be held by one hand and has a generally rounded or oval crosssection. The handle housing front surface 28 has a grip area 32 shapedto be easily gripped by one hand while the handle housing back surface30 is generally straight. Preferably the front surface 28 of the upperend 26 portion of the handle housing 12 extends a distance from the griparea 32 to form a tapered trigger attachment portion 34. The lower end24 of the handle housing 12 is generally flat and may be adapted to bereceived in a recharging unit (not shown) capable of recharging thebattery contained within the handle housing 12. The upper end 26 of thehandle housing 12 has a shaft opening (not shown) through which arotatable shaft 36 extends therethrough as described hereafter. Theupper end 26 of the handle housing 12 secures the lower end 38 of thepump housing 14. Preferably the upper end 26 of the handle housing 12 isformed so that the pump housing 14 selectively snaps onto and off of thehandle housing 12 removably securing same.

A housing component space 40 is formed inside the handle housing 12 andis sized to receive a battery 42, motor 44 and gear box 46. In apreferred embodiment, a battery 42 is disposed near the lower end 24portion of the handle housing 12 in the component space 40 and isoperatively connected to a motor 44 positioned above the battery 42 asshown in FIG. 1 to provide electrical current thereto. Mounted on themotor 44 is a gear box 46 having a upper end 48 and a lower end 50. Arotatable shaft 36 extends a distance from the upper end 48 of the gearbox 46 through a shaft opening (not shown) in the upper end 26 of thehandle housing 12 and into the pump housing 14 through the pump housingshaft aperture 52 (FIG. 5). The battery, motor and gear box of thecordless screwdriver model #9018 made by Black and Decker of Shelton,Conn. may be used in accordance with the present invention.

The electrical current to the motor 44 is selectively provided by amicroswitch 54 having an opened and a closed position interposed betweenthe battery 42 and the motor 44 for establishing electrical continuitytherebetween. When the microswitch 54 is in a closed position,electrical continuity between the battery 42 and the motor 44 isestablished and the motor 44 is in a driven or on condition. Electricalcontinuity between the motor 44 and the battery 42 is interrupted whenthe microswitch 54 is in the open position as schematically shown inFIG. 9.

The microswitch 54 is positioned in the handle housing component space40 near the trigger 56. The microswitch 54 also comprises a microswitchbutton 58 disposed between the microswitch 54 and the trigger 56 so thatthe trigger 56, when pressed, can selectively contact the microswitchbutton 58. Contact of the microswitch button 58 by the trigger 56conditions the microswitch 54 in the closed position.

The trigger 56 may be secured to either the handle housing 12 or thepump housing 14. In a preferred embodiment shown in FIG. 1, the trigger56 is pivotally secured to the trigger attachment portion 34 of thehandle housing 12. The trigger 56 has a tapered lower end 60, anenlarged ball-shaped upper end 62, an inwardly curved finger surface 64and an outwardly curved back surface 66. The trigger 56 is pivotallysecured at about the middle of the trigger to the trigger attachmentportion 34 of the handle housing 12 by a pin 68 through aligned pinholes (not shown) in the trigger attachment portion 34 of the handlehousing 12 and the trigger 56. The upper end 62 portion of the trigger56 is received in the handle housing component space 40 with the upperend of the trigger 56 extending through the lower end 38 of the pumphousing 14 through the trigger aperture 70 (FIG. 5) with the upper end62 of the trigger 56 positioned in the trigger tip opening 72 of thetrigger slide 74 (FIG. 4) as described hereafter.

The trigger back surface 66 contacts the microswitch button 58 when thetrigger finger surface 64 is pressed towards the front surface 28 of thehandle housing 12. A trigger spring 76, having an upper end 78 and alower end 80, is attached near the microswitch button 58 by the upperend 78 thereof. The lower end 80 thereof extends a distance from themicroswitch 54, between the trigger back surface 66 and the microswitch54 so that when the trigger 5 is pressed the trigger back surface 66contacts the lower end 80 of the trigger spring 76 thereby compressingthe trigger spring 76. When the trigger 56 is no longer pressed, thetrigger spring 76 resiliently returns to the decompressed positionthereby repositioning the trigger 56 in the off position.

A trigger slide aperture 82 having a first end 84 and a second end 86 isformed in the pump housing component space 93 and sized to receive atrigger slide 74 with attached slide spring 88 in an extended position.Referring to FIGS. 13 and 14, the trigger slide 74 comprises a first endplate 90, a second end plate 92, a top plate 94, a bottom plate 96 and aback plate 98. The top plate has a front end 100, a back end 102, afirst end 104 and a second end 106 and comprises a control memberopening 108 near the first end 104 portion of the top plate 94 sized tosecure the upper end 110 of the control member shaft shown in FIG. 15.The bottom plate 96 has a front end 112, a back end 114, a first end116, and a second end 118 and comprises a control member opening 120near the first end 116 portion of the bottom plate 96 sized to securethe lower end 122 control member shaft shown in FIG. 15. The controlmember openings 108 and 120 are aligned so that the control member, asdescribed hereafter, secured therein is supported in an uprightposition.

As shown in FIGS. 1 and 4, the bottom plate 96 further comprises atrigger tip opening 72 which removably receives the trigger upper end62. The top plate 94 and the bottom plate 96 are generally horizontallypositioned with a back plate 98 secured therebetween at the back end 102of the top plate 94 and the back end 114 of the bottom plate 96. A firstend plate 84 and the second end plate 86 are in a generally verticalposition. Referring to FIG. 14, the first end plate 90 secures the firstend 104 of the top plate 94, the first end 116 of the bottom plate 96and a portion of the back plate 98; the second end plate 92 secures thesecond end 106 of the top plate 94, the second end 118 of the bottomplate 96 and a portion of the back plate 98.

The control member 124 (FIG. 15) comprises a cylinder 126 having anouter periphery 128 rollingly supported on a shaft 130 having an upperend 110 and a lower end 122 extending a distance from each end of thecylinder 126. The upper 110 and lower 122 ends of the control membershaft 130 are respectively secured in the control member opening 108 ofthe top plate 94 and the control member opening 122 in the bottom plate96. The control member 124 secured in the trigger slide 74 is therebyselectively positioned to compress the flushing solution connector(interrupt position) or decompress the flushing solution connector(enable position) as shown in FIG. 7 and as described hereafter.

The slide spring 88 has a first end 132 secured to the trigger slidefirst end plate 90 and a second end 134 secured to the pump housing 14adjacent to the first end 84 of the trigger slide aperture 82.

In operation, a finger presses the finger surface 64 of the lower end 60of the trigger 56 towards the handle housing front surface 28 therebycontacting the trigger spring 76 and the microswitch button 58 toestablish the on position for the trigger 56. This moves the upper end62 of the trigger 56 engaged in the trigger tip opening 72 of thetrigger slide 74 in the opposite direction thereby compressing the slidespring 88. The control member 124, attached to the trigger slide 74, isthereby positioned so that the flushing solution connector 254 isdecompressed and flushing substance may be aspirated therethrough asdescribed hereafter. When the trigger 56 is no longer pressed by theoperator, the trigger spring 76 decompresses returning the trigger slide74 with attached control member 124 and trigger 56 to the originalposition. Since the microswitch button 58 is no longer contacted, themicroswitch 54 is in the open position conditioning the motor in an offposition.

The pump housing 14 comprises an upper surface 138, a lower surface 38,a first end 142 and a second end 144. A pump housing component space 93is formed within the pump housing 14 intersecting the first end 142 andthe second end 144. The first end 142 of the pump housing 14 has aneedle receiving opening (not shown) to receive a needle 16.

In a preferred embodiment shown in FIG. 1, an annular needle receivingadaptor 146 has a first end 148 and a second end 150 with an openingtherethrough (not shown). The adaptor second end 150 portion is securedin the opening of the pump housing first end 142 and secures either atubing first end 230 as shown in FIG. 1 or a tubular projection 242 withattached shoulder 248 as shown in FIG. 7 and described hereafter. Theadaptor first end 148 removably secures a luer lock needle attachment(not shown) secured to the second end of the needle 16.

FIGS. 2 through 5 show the pump housing 14 in horizontal block crosssections as used in the manufacturing process of a preferred embodiment.These same sections may be shaped to conform to the outer dimensions ofthe pump housing shown in FIG. 1. FIG. 5 represents the lowest sectionupon which respectively the sections in FIGS. 4, 3 and 2 are mounted.FIG. 5 shows the pump housing shaft aperture 52 which receives the shaft36 from the gearbox 46 and the trigger aperture 70 which receives theupper end 62 of the trigger 56. FIG. 2 shows the support post opening 99which receives the upper end 174 of the support post 172 as describedhereafter.

After the appropriate components as described hereafter have beendisposed in the pump components space 93, a bolt (not shown) secured ineach of the aligned bolt apertures 149 secures the pump housing sectionstogether. The pump housing sections form a pump housing component space93 which intersects the first end 142 and the second end 144 of the pumphousing 14.

A portion of the pump housing component space 93 comprises aneccentrically formed bowl-like rod support member space 158 whichreceives the rod support member 160 and comprises a continuous firstfront wall 162 (FIG. 3) and second front wall 164 (FIG. 4), a continuousfirst back wall 166 (FIG. 3) and second back wall 168 (FIG. 4) and aside wall 169. The space between the outer periphery 192 of the rods 198of the rod support member 160 and the walls of the rod support memberspace 158 dictate whether the connectors disposed in that space arecontacted by the rod support member 160, i.e., if that space is smallerthan the diameter of the connectors the rods of the rod support memberwill compressingly engage the connectors. This engagement creates avacuum in the connectors. Thus the shape of the rod support member spaceselectively controls the amount of contact between the connectors andthe rods and therefore the degree of vacuum created in the connectors.

The pump housing component space 93 further comprises a first biosamplecanal 258 and a second flushing canal 256 that intersect at the firstend 142 portion of the pump housing 14 and lead to the rod supportmember space 158 in about the middle of the pump housing 14. A firstflushing canal 276, a second biosample canal 260, an upper additivecanal 312 and a lower additive canal 300 lead from the rod supportmember space 158 to the second end 144 portion of the pump housing 14.The canals 256, 258, 260, 276, 312 and 300 are sized to receive aconnector therein as described hereafter.

As previously described, a shaft 36 from the gear box 46 extends intothe rod support member space 158 and is engagingly received in thesupport post aperture 170 of the rod support member 160 (FIG. 11) sothat as the shaft 36 rotates, the rod support member 160 rotates. Therod support member 160 comprises a support post 172 having an upper end174 and a lower end 176 The lower end 176 of the support post 172 has anaperture 170 (FIG. 10) sized to engagingly receive the shaft 36.Preferably the shaft 36 is hexagonal and sized slightly smaller than thehexagonally shaped aperture 170 in the support post 172.

Referring to FIG. 11, the rod support member 160 further comprises anannular upper rod support 178 secured to the upper end 174 portion ofthe support post 172 having a lower face 180, an upper face 182 and anouter periphery 184, and an annular lower rod support 186 secured to thelower end 176 portion of the support post 172 having a lower face 188,an upper face 190 and an outer periphery 192. The upper rod support 178and lower rod support 186 include a plurality of rod receiving slots 194spaced a distance around the periphery 184 and 192 of the rod supports178 and 186. The slots 194 are shaped and positioned so that a rod shaft196, as described hereafter, can snap into the slots and be securelysupported in an upright position around the rod support member 160.

As shown in FIG. 12, the rod 198 comprises a rod cylinder 200 having anouter periphery 202 rollingly supported on a rod shaft 196 wherein theshaft has an upper end 204 and a lower end 206 which extends a distancefrom opposite ends of the rod cylinder 200. The upper end 204 of the rodshaft is sized to snap into rod receiving slot 194 in the periphery 202of the upper rod support 178; the lower end 206 of the rod shaft 196 issized to snap into the rod receiving slot 194 in the lower rod support186 thereby securing the rod 198 in an upright position in the rodsupport member 160. Secured in this manner, the outer periphery 202 ofthe rod cylinder 200 extends a distance from the rod support member 160to rollingly engage a portion of the connectors as described hereafter.

In a preferred embodiment, a peristaltic pump comprising four rods 198secured at equispaced distances in the foregoing manner in the rodsupport member 160 providing a circular configuration of rotatable rods198 is utilized in accordance with the present invention. When the motor44 is in the on position, the shaft 36 rotates which rotates the rodsupport member 160 having the rods 198 secured thereto. Selectedconnectors, as described hereafter, are alternately compressed by therods 198 in a peristaltic movement when the outer periphery 192 of eachrod 198 rolls along the connectors thereby compressing the connectors.This engagement of the connectors by the rods 198 creates a vacuum inthe connectors and attached needle 16.

Instead of the peristaltic pump described in the foregoing, the presentinvention may use any other type of pump which appropriately providesthe necessary vacuum action in the biosample collection system. FIG. 19shows an embodiment of the present invention which utilizes a pistonpump 209 driven by a motor source. The piston pump 209 produces a vacuumin the biosample collection system and the needle 215. The biosamplecollection system comprises a biosample container 211, biosampleconnector 213, additive connector 217, additive container 219, flushingconnector 254 and flushing container 223.

At least one container is disposed in the pump housing component space93 near the second end 144 of the pump housing 14.

As shown in FIG. 1, a preferred embodiment of the second end 144 of thepump housing 14 comprises a clear plastic container compartment 208having a first end 210, a second end 212, an upper surface 214, a lowersurface 216 and a container component space 218 formed therein which ispart of the pump housing component space 93 and is sized to receive oneor more containers. The container compartment 208 is secured to thesecond end 144 portion the pump housing 14 so that the upper 214 andlower surface 216 of the container compartment 208 are about flushrespectively with the upper 138 and lower 38 surfaces of the second end144 portion of the pump housing 14 and has the same general crosssection as the second end 144 portion of the pump housing 14.

A biosample container 220 having a collection space 222 sized to receiveat least one biosample is disposed in the second end 144 portion of thepump housing component space 93 and preferably in the containercomponent space 218. The biosample container 220 must be able towithstand the suction pressure exerted by the pump. In a preferredembodiment, the biosample container 220 is an elastomeric sack. Inanother embodiment, the biosample container 220 is a molded flexiblepolyurethane compartment.

The collection space 222 of the biosample container 220 is incommunication with the second end of the needle 16 so that a biosamplecollected by the needle 16 may be deposited in the collection space 222of the biosample container 220. Preferably this communication isestablished by a biosample connector 228 having a first end 230, asecond end 232, an outer periphery 233 and an opening (not shown)therethrough. In a preferred embodiment, the biosample connector 228 iselastomeric tubing.

The second end 232 of the biosample connector 228 is secured to abiosample container 220 so that the collection space 222 hereof is incommunication with the opening in the biosample connector 228. The firstend 230 of the biosample connector 228 is connected to the second end ofthe needle 16. As shown in FIG. 7, this connection may be accomplishedby a conduit 236 having a first 238, second 240 and third 242 tubularprojection extending therefrom thereby forming a T tubing. The terminalends of the first, second, and third tubular projections have securedthereto respectively a first 244, second 246 and third 248 annularshoulder, having a first end 250 and a second end 252 wherein the secondend 252 faces the conduit 236. There is an increase in size of theshoulder towards the conduit whereby the first end 250 of the shoulderhas a smaller outside diameter than the second end 252 of the shoulder.The biosample connector 228 is sized to slide easily over the first end250 of the shoulder 244 but must be forced over the second end 252 ofthe shoulder thereby securing the connector 228 to the tubularprojection 238.

As previously described the second end of the needle 16 is incommunication with the opening of the third shoulder 248 therebyestablishing fluid communication between the first end 18 of the needle16 and the collection space 222 in the biosample container 224. In apreferred embodiment, a flushing connector 254 is secured to the secondshoulder 246 in the same manner as the first shoulder 244 to providefluidic communication for the flushing substance to the biosampleconnector 228 as described hereafter. Another embodiment shown in FIG. 1eliminates the need for the T tubing by fusing the flushing connector254 to the biosample connector.

The first end 230 portion of the biosample connector 228 is positionedin the first biosample canal 258 of the pump housing component space 93(FIG. 3) and follows the first back wall 166 of the rod support membercomponent space 158. The second end 232 portion of the biosampleconnector 228 is positioned in the second biosample canal 260 whichleads to the pump housing second end 144 portion containing thebiosample container 220. The space between the first back wall 166 ofthe rod support member space 158 and the rods 198 is less than thediameter of the biosample connector 228 so that positioning thebiosample connector 228 in this space permits the rotating rods 198 ofthe rod support member 160 to compressingly engage the biosampleconnector 228 as in FIG. 7 thereby creating a suction therein.

As shown in FIGS. 1 and 8, a flushing container 262 is positioned in thecontainer compartment component space 218 and has a flushing substancespace 264 formed therein sized to retain an effective amount of aflushing substance such as sterile normal saline solution. The flushingcontainer 262 is preferably made from the same material as the biosamplecontainer 220.

A flushing connector 254 having an outer periphery 268, a first end 270and a second end 272 with a connector opening (not shown) formedtherethrough is shown in FIGS. 1 and 7. The second end 272 of theflushing connector 254 is connected to the flushing container 262 sothat the flushing connector opening is in fluid communication with theflushing substance contained in the flushing container 262. In thepreferred embodiment shown in FIG. 7, the first end 270 of the flushingconnector 254 is secured to the second tubular projection 240 aspreviously described so that the flushing connector opening is in fluidcommunication with the biosample connector opening (not shown). In thepreferred embodiment shown in FIG. 1 the first end 270 of the flushingconnector 254 is fused at approximately a 30° angle to the biosampleconnector 228 to establish fluidic communication therebetween.Preferably the flushing connector is elastomeric tubing.

The second end 272 portion of flushing connector 254 is positioned inthe first flushing canal 276 and contactingly follows the first frontwall 162 to the second flushing canal 256. The space between the firstfront wall 162 and the outer periphery 202 of the rod cylinders 200 islarger than the diameter of the flushing connector 254 so the flushingconnector 254 is not engaged by the rods 198 (FIG. 7). The flushingsubstance within the flushing container 262 is aspirated through theflushing connector opening by the suction created in the biosampleconnector 228 in communication therewith. The flow of the flushingsubstance is interrupted by selectively compressing the flushingconnector 254 with the outer periphery 128 of the control membercylinder 126 as shown in FIG. 7 and as previously described.

A third container may be disposed in the second end 144 portion of thepump housing component space 93 which contains an additive. The additivecontainer 278 comprises an additive space 280 formed therein sized toretain an effective amount of additive and is preferably made from thesame material as the biosample container 220. The additive container 278is in communication with an additive connector 282 having a first end284 and a second end 286 with an opening (not shown) therethrough and anouter periphery 290. Preferably the additive connector is elastomerictubing.

The first end 284 of the additive connector 282 is secured to theadditive container 278 and the second end 286 of the connector 282 issecured to the biosample container 220 or a portion of the biosampleconnector 228 near the biosample container 220 so that the additive isin communication with the collection space 222 of the biosamplecontainer 220. The additive preferably does not enter the biosampleconnector 228 in a manner which could inadvertently contaminate thebiosite with additive.

The first end 284 portion of the additive connector 282 is positioned inthe lower additive canal 300 (FIG. 4.) and follows the second front wall164, the side wall 169 and the second back wall 168 of the rod supportmember space 158 and into the upper additive canal 312 which leads tothe biosample container 220. The space between the rods 198 and thewalls of the rod support member space 158 is smaller than the diameterof the additive connector 282 so that the rotating rods 198 contact theadditive connector 282 as shown in FIG. 7 creating a vacuum therein.

Referring to FIG. 20, the flow of the additive through the additiveconnector 282 can be regulated by an additive regulator generallydesignated by the numeral 283 which selectively compresses at least aportion of the additive connector 282. A ball 314 is disposed in thepump housing component space 93 near the upper additive canal 312 sothat the ball compresses the additive connector 282. Between the ball314 and the inside wall of the pump housing 316, preferably in arecessed area, is disposed a ball spring 318. A ball rod 320 is securedat one end to the ball 314 and extends a distance from the pump housing14 at the opposite end. An additive button 322 is secured to the end ofthe ball rod 320 which extends from the pump housing 316. When theadditive is desired in the biosample container 220, the additive button322 is pressed which extends the ball rod 320 thereby displacing theball 314 from the compressed additive connector 282 which permits theflow of the additive therethrough. When the additive button 322 is nolonger pressed the ball spring 318 resiliently returns to a decompressedpositioned which pushes the ball onto the additive connector 282compressing same.

As previously described, a commercially available needle may be usedwith the aspirator of the present invention. Alternately, the followingneedles may be utilized.

The flushing needle shown in FIG. 16 and generally designated by thenumeral 324, comprises a first shaft 325 having a first end 326 capableof cutting and receiving a biosample, a second end 328 attachable to aneedle receiving member 329 such as the aspirator of the presentinvention, a duct 330 having a first end 331 and a second end 333intersecting the first 326 and the second ends 328 of the first shaft325. The first shaft 325 is capable of receiving an effective amount offlushing substance such as sterile normal saline solution in the firstend 331 portion of the duct 330. In a preferred embodiment flushingsubstance is supplied to the first end 331 portion of the duct 330 bytelescoping a second shaft 335 over the first shaft 325. The secondshaft 335 comprises a first end 337 and a second end 339 secured to thefirst shaft 325 and a flushing substance space 341 formed between thefirst end 336 and the second end 339 of the second shaft 335. Flushingsubstance received by the flushing substance space 341 is received inthe first end 331 portion of the duct 330 via a port 332 in the firstend portion of the first shaft 325.

FIG. 16 shows a flushing solution reservoir attached to a second shaftport 334 positioned near the second end portion 339 of the second shaft335; a valve 336 regulates the flow of flushing substance therebetween.The flushing solution is received in the flushing substance space 341which is then received in the first end 331 portion of the duct 330 viaport 332. A portion of the flushing solution is received at the biositefrom the duct 330. A biosample is received by the first end 331 of theduct 330 and the flushing solution aids in the delivery of the biosampleto the second end 333 thereof. Providing flushing substance to the firstend portion of the duct and the biosite aids in obtaining andtransferring biosamples from the biosite to a needle receiving member329.

The obturator needle shown in FIG. 17 and generally designated by thenumeral 340, comprises a shaft 343 having first end 342 capable ofcutting and receiving a biosample, a second end 344 attachable to aneedle receiving member 329 such as the aspirator of the presentinvention and an opening 346 intersecting the first end 342 and thesecond end 344 of the shaft 343. An obturator 348 having a first end 350and a second end 352 is disposed in the opening 346 so that theobturator first end 350 blocks the opening of the first end 342 of theshaft 343. The opening 346 near the first end 342 of the shaft 343 istapered and sized slightly larger that the diameter of the obturator348. The remainder of the opening 346 is larger and sized to receive theobturator 348 and a biosample received by the first end 342 of the shaft340. The second end 352 of the obturator 354 is attached to a means forwithdrawing the obturator 354 a distance from the shaft first end 342past the tapered portion of the opening 346 so that a biosample can bereceived by the needle first end 342 of the shaft 343. The withdrawingmeans is shown as an obturator trigger 354 in FIG. 17. The obturatorneedle 340 is used when several layers of tissue must be puncturedbefore reaching the biosite. The obturator 348 prevents obtainingunwanted tissue samples until the first end of the needle is positionedat the biosite.

The flange needle shown in FIG. 18 and generally designated by thenumeral 356 comprises a shaft 357 having a first end 358 capable ofcutting and receiving a biosample, a second end 360 attachable to aneedle receiving member 329 such as the aspirator of the presentinvention, an opening (not shown) intersecting the first 358 and thesecond 360 ends and an outer periphery 364. A flange member 366 issecured to the outer periphery 364 at a selected position in order toprevent further insertion of the needle 356 into a biosite. Inoperation, the first end 358 of the shaft 357 is inserted into thebiosite such as a prostate gland. The flange member 366 acts as a guideto the operator to determine how far the shaft 357 has been inserted,and prevents a further insertion of the shaft 357 into an area past theprostate gland which could recover a biosample from an unintendedbiosite. Preferably the flange member 366 is made from the same materialas the needle 356 and may be any shape which is large enough to form astop surface in order to prevent inadvertent insertion into the patient.In a preferred embodiment for use in prostate gland, the flange member366 is positioned 1.5 inches from the first end 358 of the shaft 357.

In one operation, the first end 18 of the needle 16 is positioned at thedesired biosite such as a prostate gland. The first end 18 of the needle16 cuttingly engages the prostate gland thereby receiving a tissuebiosample in the opening of the first end thereof. The trigger 56 ispressed which activates the pump thereby establishing a vacuum capableof continuous vacuum directly in the biosample connector 228 andindirectly in the needle opening. The biosample is aspirated through theneedle opening, through the biosample connector 228 and into thecollection space 222 in the biosample container 220.

Pressing the trigger 56 moves the control member 124 thereby permittingthe flushing substance to be aspirated through the flushing connector254 by the suction created in the biosample connector 228 by the pump.The flushing substance is delivered to the biosample connector 228 andaids in the delivery of the biosample to the collection space 222 byflushing the biosample into same.

When the trigger 56 is pressed by the operator, the pump creates asuction in the additive connector 282. The additive button 322 ispressed thereby decompressing the additive connector 282 which permitsthe transfer of the additive to the biosample container. The additivemay be any agent which aids in preserving, treating or analyzing thebiosample. The present invention is especially useful if the additive oradditives can identify a condition in the biosample which aids in theimmediate diagnosis of the patient. This would eliminate the time andexpense of the biosample being analyzed in the laboratory or for thepathologist to be present in the operating room.

After the first biosample is delivered to the collection space 222,multiple biosamples may be obtained by repositioning the first end 18 ofthe needle 16 to obtain the next desired biosample and repeating thepreviously described procedure. After the desired biosample orbiosamples have been obtained, the trigger is returned to the offposition and the aspirator withdrawn from the biosite. The pump housing14 is snapped off and sent to the laboratory for appropriate analysis ofthe biosample or the biosample is viewed through the clear plasticcontainer compartment for the appropriate response. A new pump housing14 is snapped on the handle housing 12 to obtain the next biosample.

In the laboratory the pump housing 14 containing the biosamples issnapped onto a handle housing 12 having a reverse motor position. Thereverse motor position is engaged and the biosamples are aspirated fromthe biosample container 220, through the biosample connector 228 andneedle 16 and into a container for analysis. Thus laboratory personnelneed never touch the biosample.

Changes may be made in the construction and operation of the variousparts, elements and assemblies described herein and in the steps or inthe sequence of steps of the methods described herein without departingfrom the spirit and scope of the invention as defined in the followingclaims.

What is claimed is:
 1. A method for collecting a biosample at a selectedbiosite from a subject using an aspirator adapted for use in collectinga biosample and for use with a needle having a first end and a secondend with a needle opening extending therethrough and intersecting thefirst and the second ends thereof, the biosample being collected in abiosample collection system in communication with the needlecomprising:providing a biosample collection system; holding thebiosample collection system in one hand, the biosample collection systembeing held in close proximity to the subject; inserting the needle intothe subject and positioning the first end of the needle at the selectedbiosite to receive the biosample; receiving at least a portion of abiosample into the opening of the first end of the needle; activatingthe biosample collection system to engage the biosample in the needle topermit transport of the biosample into the biosample collection system,wherein said step of providing comprises providing a biosamplecollection system comprising: a biosample collection area comprising abiosample container having a biosample collection space adapted forreceiving the biosample therein, a pump connected to the biosamplecollection space for establishing a suction means within the biosamplecollection system, a drive means connected to the pump for activatingthe pump in a driven condition, a communicating means for establishingfluidic communication between the needle opening and the biosamplecollection area, an activating trigger connected to the drive means andto the communicating means for activating the pump and fluidiccommunication between the needle opening and the biosample container, abiosample connector having a first end and a second end and a connectoropening extending therethrough intersecting the first and second endsthereof, the first end of the biosample connector engaging the secondend of the needle and the second end of the biosample connector engagingthe biosample container, the biosample connector capable of transportingthe biosample engaged in the needle to the biosample container; a pumphousing having a first end, a second end and a pump housing componentspace formed generally between the first end and the second end of thepump housing, the pump housing having an upper surface and a lowersurface, the biosample connector being disposed in the pump housingcomponent space and extending generally between the first end and thesecond end of the pump housing, the second end of the needle beingconnectable to the first end of the biosample connector and the needlebeing extendable a distance generally from the first end of the pumphousing, the biosample container being connected to the second end ofthe biosample connector generally near the second end of the pumphousing, the pump being disposed in the pump housing component space,and a handle housing adapted to be gripped by an individual when theaspirator is being used for obtaining a biosample having an upper endand a lower end, a handle component space being formed in a portion ofthe handle, a portion of the drive means being disposed generally withinthe handle component space and a portion of the drive means beingdisposed generally within the handle component space and a portion ofthe drive means extending from the handle component space a distancegenerally above the upper end of the handle housing and being connectedwith the pump in the pump housing component space; gripping the trigger,thereby activating the drive means of the pump and the communicatingmeans, causing the pump to generate a suction, and causing fluidiccommunication between the needle and the biosample collection area to begenerated; establishing a vacuum capable of continuous suction in thebiosample collection system; aspirating a biosample from the first endof the needle and the needle opening and movably transferring thebiosample through the needle opening and through the biosample connectorto the biosample collection space; and flushing the biosample from thefirst end of the needle and the needle opening to the biosamplecollection space, wherein the communicating means establishes fluidiccommunication between the needle and the biosample collection space toaid in the delivery of the biosample to the biosample collection space.2. The method of claim 1 further comprising cuttingly engaging thebiosite to receive a biosample in the opening of the first end of theneedle.
 3. The method of claim 1 further comprising:repositioning thefirst end of the needle, after inserting the needle in the subject andafter collecting the first biosample, to position the first end of theneedle at a second biosite to receive a biosample in the opening of thefirst end of the needle; and establishing a vacuum by way of the meanscapable of generating a continuous vacuum for sucking the secondbiosample collected at the second biosite through the needle opening andthe biosample collection system.
 4. The method of claim 3 repositioningthe first end of the needle in the subject to be disposed nearsubsequent biosites, after collecting the second biosample; andestablishing a vacuum at least at each time the first end of the needleis positioned at each subsequent biosite for sucking subsequentbiosamples through the needle opening and into the biosample collectionsystem.
 5. The method of claim 3 wherein the biosample collection systemcomprises a biosample container having a collection space sized toreceive at least one biosample.
 6. The method of claim 5 furthercomprising: adding at least one additive to the collection space.
 7. Themethod of claim 1 further comprising:flushing the biosample into thebiosample collection system by introducing a flushing substance in aportion of the biosample collection system.
 8. The method of claim 1further comprising:flushing the biosample into the biosample collectionsystem by introducing a flushing substance in a portion of the needleopening.
 9. The method of claim 1 wherein the biosample collectionsystem further comprises:removing the pump housing from the handlehousing by unsnapping the pump housing from the handle housing, sendingthe pump housing and the biosample contained within the biosamplecontainer in the pump housing to a laboratory for analysis of thebiosample.